Xalacom

Medicinal product

(Invented) name

Xalacom

Active substance (s)

Latanoprostas/Timololis

Strength

50 µg/5 mg/ml

Pharmaceutical form

akių lašai (tirpalas)

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01ED51, Timolol, combinations

Marketing authorisation holder

Upjohn EESV, Nyderlandai

Date of authorisation

2001-10-08

Date of renewal

2010-12-20

Documents

2262 Pakuotės lapelis 2023 10 12.docx

2262 Xalacom II PL 2023 10 12.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Latanoprostas	50 µg
Timololis	5 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
3188	3991	1003991	buteliukas	2,5 ml N1		Receptinis	LT/1/01/2262/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2010-12-20	Perregistruotas
2001-10-08	Registruotas